1. Field of the Invention
This invention generally relates to systems for allowing selective fluid communication between fluid containers, such as medicant and/or medical fluid containers. More particularly, the invention relates to fluid containers of the type having a port adapted for receiving a medicant container for mixing with a fluid within the medical fluid container and an administration port for delivery of the combined medicant and fluid.
2. Description of Related Art
Medical solutions are provided in containers of several different constructions. For many years and even today solutions were provided in rigid containers such as glass containers. Other containers are not rigid but exhibit varying degrees of flexibility. These containers include blow molded containers which may be constructed of plastics including high density polyethylene. Containers made out of films form another type of flexible or non-rigid containers. Such containers or bags are typically formed of two flexible sheets or films of material joined at their peripheral edges by well-known methods, such as sonic, heat, or RF sealing.
Containers for medical solutions may contain one or more ports to allow the administration of a preferred solution to a patient. For example, the container may include a separate injection and administration port. The injection port allows a fluid to be added to the contents of the container while maintaining the sterility of the container. The administration port allows connection of the contents of the container to an administration set so that the contents may be provided to a patient.
In flexible containers, the containers include separate fill and administration ports which extend through a wall or seam of the bag. More specifically, such ports typically include plastic tubular members bonded within the peripheral seal, which allow for communication between an interior of the bag and the exterior. The tubular members are temporarily sealed by any of a number of conventional sealing devices, such as a pierceable diaphragm or frangible cannula, which are also all well known to those skilled in the medical fluid container field.
As noted above it is often necessary to mix a medication with the contents of a medical fluid container to dilute or reconstitute a medicament for administration to a patient. These medications are frequently provided in a glass vial closed by a pierceable rubber stopper or septum. From time to time herein, the terms “vial,” “vial connection port,” and other uses of the word “vial” will be used in reference to a medical container, but it should be understood that the present invention is not limited to use with a glass vial, but can be applied to any medicant container which includes a connection system which allows access to the contents of the container for reconstitution and/or withdrawal. Also, as used herein “reconstitution” or “reconstituting” includes reconstitution or reconstituting a dry or powder medicant, dilution or diluting a medicant, either powder or liquid, and other mixing of medicants in the vial and/or container.
If the medicant in the vial is provided as a fluid it may be withdrawn from the vial and added directly to the medical fluid container for administration to a patient. In other situations where the medicant is lyophylized, liquid is first introduced into the vial to reconstitute the medicament, and then the reconstituted medicament is withdrawn from the vial and injected into the container. In some examples liquid used to reconstitute the medicant may be withdrawn from the solution container. One way to accomplish this is to form a direct connection between the vial and the container. In this regard it was previously known to provide a port on the top end edge of a medical fluid container for engaging and supporting the separate medicament container.
In such known containers with a vial connection port at the top, it is known to employ a piercing member axially movable within the port to pierce the septum of the vial to provide access to the contents. Alternatively, the piercing member may be stationary, while the vial is movable relative to the piercing member. The piercing member may also include a lumen through which a medicant and/or medical fluid may pass between the interior of the bag and the vial.
When the vial medicant enters the interior of the bag, it mixes with a fluid already contained within the bag (“the bag medicant”). The vial medicant and bag medicant are mixed until they form a treatment fluid. The administration port at the bottom end of the bag is then opened and the treatment fluid is delivered to a patient through a separate administration tubing set connected to the administration port.
Variations of the above-described reconstitution system are illustrated in U.S. Pat. No. 4,410,321; 4,411,662; 4,432,755; 4,583,971; 4,606,734; 4,936,841; 5,308,347; 5,352,191; 5,364,386; and 5,826,713; each being hereby incorporated herein by reference.
Heretofore, the vial connection port and administration ports of the above containers have typically been provided at opposite ends of the bag in order to allow for the contents of the vial to utilize gravity to flow from the vial, through an upper inlet or connection port, and into the bag interior, then out of the bag through a lower administration port. This configuration, however, requires multiple openings at opposite ends of the peripheral seal of the bag, including at least one at the vial connection port and another at the administration port, which increases the cost and complexity of assembling the bag. Further a location for connection of the vial at the top of the bag can be awkward and inconvenient for hanging the bag. On the other hand, placing the vial connection at the bottom of the container may cause fluid to drain and remain in the vial and not be administered to the patient.
Also, with known containers used for reconstituting medications in vials, the associated piercing member for accessing the vial contents typically has an open lumen, which provides continuous fluid communication between the vial and the container interior immediately after the vial stopper has been pierced. Known reconstitution containers generally do not allow for interruption or control of fluid flow between the vial and container after fluid communication is established, and therefore require that the vial and container remain attached to avoid leakage or contamination. This does not allow for accessing multiple vials should the prescription call for such concentrations.
As set forth in more detail below, the present invention provides an improved container and container system for medicant reconstitution that have several aspects that may be employed separately or together to address one or more of the above drawbacks of prior containers and systems.